Full-time

Syneos Health is hiring a Safety & PV Specialist I

About the Role

Syneos Health is hiring a Safety & PV Specialist I to ensure the accurate review and reporting of safety data within clinical trials. We are passionate about developing our people and building a place where everyone feels like they belong.

What You'll Do

  • Perform comprehensive medical review and clarification of trial-related Adverse Events, ensuring accurate documentation and timely reporting.
  • Provide detailed aggregate reviews of safety information, identifying potential safety signals and trends.
  • Serve as an internal consultant to pharmacovigilance case processing teams, offering expert guidance on complex safety issues.
  • Contribute to the detection of safety signals and trends through rigorous analysis of safety data.
  • Conduct thorough risk management assessments and recommend appropriate mitigation strategies.
  • Provide proactive safety support to clinical development teams to enhance trial quality and safety.
  • Participate in all aspects of the medical safety team's involvement in assigned trials, including protocol development and monitoring.
  • Ensure accurate and timely reporting of safety information, maintaining high standards of data integrity.
  • Enhance the overall quality and safety of clinical trials by implementing best practices.

What We're Looking For

  • Bachelor's degree in a relevant field (e.g., Pharmacy, Medicine, Life Sciences).
  • Minimum of 1-2 years of experience in pharmacovigilance or a related field.
  • Strong understanding of clinical trial processes and safety regulations.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Proficiency in medical review and safety signal detection.
  • Ability to manage and interpret complex safety data.
  • Strong attention to detail and accuracy.
  • Ability to work independently and as part of a team.
  • Proficiency in using pharmacovigilance databases and software.

Nice to Have

  • Certification in Pharmacovigilance or Drug Safety.
  • Relevant professional certifications (e.g., PMP, Six Sigma).

Technical Stack

  • Pharmacovigilance databases and software.

Benefits & Compensation

  • Career development and progression.
  • Supportive and engaged line management.
  • Technical and therapeutic area training.
  • Peer recognition and total rewards program.

Syneos Health is an equal opportunity employer.

Required Skills
pharmacovigilancedrug safetyregulatory compliancemedical codingcase processingliterature screeningclinical trialsICH guidelinesGCPmedical terminologySOPsaggregate reportssignal detection
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About company
Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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Job Details
Category other
Posted 7 months ago